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Solifenacin

    DEA Class;  Rx

    Common Brand Names; VESIcare, VESIcare LS

    • Anticholinergics, Genitourinary

    Oral competitive selective M3 antimuscarinic agent
    Used for overactive bladder (OAB) in adult or pediatric patients 2 years and older; in adults may be used in combination with a beta-3 adrenoreceptor agonist
    Common side effects include dry mouth or constipation; monitor for urinary retention

    Indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urinary urgency, and urinary frequency.

    For the treatment of neurogenic detrusor overactivity (neurogenic bladder).

    Hypersensitivity

    Gastric retention

    Uncontrolled narrow-angle glaucoma

    tablets only

    • Urinary retention

    Tablets

    • Blurred vision (3.8-4.8%)
    • Dry mouth (10.6-27.6%)
    • Constipation (5.4-13.4%)
    • Urinary tract infection NOS (2.8-4.8%)
    • Dyspepsia (1.4-3.9%)
    • Nausea (1.7-3.3%)
    • Influenza (0.9-2.2%)
    • Fatigue (1-2.1%)
    • Dizziness (1.8-1.9%)
    • Upper abdominal pain (1.2-1.9%)
    • Dry eyes NOS (0.3-1.6%)
    • Urinary retention (1.4%)
    • Hypertension NOS (0.5-1.4%)
    • Depression NOS (0.8-1.2%)
    • Edema lower limb (0.3-1.1%)
    • Vomiting (0.2-1.1%)
    • Cough (0.2-1.1%)

    Oral suspension

    • Constipation (7.4%)
    • Dry mouth (3.2%)
    • Urinary tract infection (2.1%)
    • Abdominal pain (1.1%)
    • Positive urinalysis bacterial test (1.1%)
    • Somnolence (1.1%)

    Reports of angioedema of face, lips and/or larynx, in some cases occurring after the first dose, described; anaphylactic reactions reported rarely

    Administer with caution with clinically significant bladder outflow obstruction

    Caution with decreased gastrointestinal motility

    Somnolence reported; advise patients not to drive or operate heavy machinery until they know how therapy affects them

    Caution in patients being treated for narrow-angle glaucoma

    Caution with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval

    Associated with antimuscarinic CNS adverse reactions; monitor for signs of antimuscarinic CNS adverse reactions, particularly after beginning treatment or increasing the dose

    There are no studies on use in pregnant females

    Adults

    10 mg/day PO.

    Geriatric

    10 mg/day PO.

    Adolescents

    weighing more than 60 kg: 10 mg/day PO.
    weighing 46 to 60 kg: 8 mg/day PO.
    weighing 31 to 45 kg: 6 mg/day PO.
    weighing 16 to 30 kg: 5 mg/day PO.
    weighing 9 to 15 kg: 4 mg/day PO.

    Children

    2 to 12 years:
    weighing more than 60 kg: 10 mg/day PO.
    weighing 46 to 60 kg: 8 mg/day PO.
    weighing 31 to 45 kg: 6 mg/day PO.
    weighing 16 to 30 kg: 5 mg/day PO.
    weighing 9 to 15 kg: 4 mg/day PO.
    1 year: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Solifenacin succinate

    tablet

    • 5mg (VESIcare)
    • 10mg (VESIcare)

    VESIcare Oral Susp: 1mg, 1mL